A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Genentech, Inc.
Summary
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Life expectancy \>=3 months, in the investigator's judgment * Adequate hematologic and end-organ function * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care * Measurable disease per RECIST v1.1 * Tumor spec…
Interventions
- DrugRO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
- DrugAtezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Locations (18)
- University of Alabama at Birmingham (UAB)Birmingham, Alabama
- Yale Cancer CenterNew Haven, Connecticut
- Icahn School of Medicine at Mount Sinai (ISMMS)New York, New York
- The Ohio State UniversityColumbus, Ohio
- Magee-Woman's HospitalHarrisburg, Pennsylvania
- SCRI Oncology PartnersNashville, Tennessee